Other products from "ELITECHGROUP MDX LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 03661540952418 M800739 The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intend The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert MS2 Internal Control DNA Template (250uL volume)
2 03661540951886 800438 800438 "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific rea "MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designedto detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis.The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6-carboxyfluorescein, which has anexcitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® Bordetella P/PP Probe Mix ASR - 48 Reactions
3 03661540951787 M800331 M800331 The MGB Alert PCR Master Mix package includes ready to use 2x master mix contain The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions. PPM General Purpose Reagent 1 MGB Alert 2X PCR Master Mix 48 rxn
4 03661540951770 800434 800434 MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that co MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. MVU Reagents, Specific, Analyte 1 MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions
5 03661540951633 800439 800439 The MGB Alert Internal Control Set IC1-V consists of reagents intended for use a The MGB Alert Internal Control Set IC1-V consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-V can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC1-V 48 rxn
6 03661540951626 800432 800432 The MGB Alert Internal Control Set IC2-C consists of reagents intended for use a The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C can be used to detectsystemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set isnot intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-C-480 rxn
7 03661540951534 800421 800421 "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a ch "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Probe Mix ASR-48rxn
8 03661540951527 800419 800419 "MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemica "MGB Alert® VZV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acidsequences within the ORF 38 region of VZV(Varicella-Zoster Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. Theprobe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® VZV Probe Mix ASR - 48 rxn
9 03661540951442 800365 800365 The MGB Alert Internal Control Set MS2-E consists of reagents intended for use a The MGB Alert Internal Control Set MS2-E consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-E can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set MS2-E
10 03661540951411 800362 800362 The MGB Alert Internal Control Set IC2 consists of reagents intended for use as The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-480 rxn
11 03661540951367 800349 800349 MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically s MGB Alert® HSV Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of one probe at 4.96 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert HSV Ensemble Probe Mix ASR - 480 rxn
12 03661540951220 M800687 M800687 "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a "MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrAgene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 andhas an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm" MVU Reagents, Specific, Analyte 1 MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions
13 03661540950254 M800580-am M800580-am The MGB Alert Internal Control Set IC2-T consists of reagents intended for use a The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-T, 09N42-001
14 03661540950247 M800580 M800580 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use a The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-T can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-T
15 03661540950162 800497-am 800497-am MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleo MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus.The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all knownAdenovirus types. MVU Reagents, Specific, Analyte 1 MGB Alert Adenovirus Primer Mix ASR, 09N40-003
16 03661540950148 800424-am 800424-am MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemical MGB Alert® EBV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from EBV (Epstein-Barr Virus). The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert EBV Probe Mix ASR, 09N39-002
17 03661540950025 1 HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and HSV 1&2 ELITe MGB Assay for the detection of HSV. A collection of reagents and other materials intended to be used for the qualitative detection of nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT). This is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutane Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples 2 HSV 1&2 ELITe MGB Assay
18 03661540950018 M800552 M800552 The United States (US) Food and Drug Administration (FDA) has issued an Emergenc The United States (US) Food and Drug Administration (FDA) has issued an Emergency UseAuthorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitroqualitative detection of Zika virus with specified instruments. This assay tests for Zika virusRNA in human serum and EDTA plasma. Zika ELITe MGB® - EUA
19 03661540951275 800332 800332 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleoti MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Primer Mix ASR - 480 Reactions
20 03661540952388 M800736 M800736 The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended f The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert IC1 Internal Control Template
21 03661540952326 M800733 MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV ASR v3.0 Probe Mix
22 03661540951824 M800694 M800694 "The MGB Alert Platinum Master Mix is intended for use in the development of lab "The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays whichtarget DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates nodiagnostic information or data." PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix with water-480rxn
23 03661540951503 800416 800416 MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleot MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2(Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleicacid sequence from the glycoprotein D region of HSV 1 and 2. MVU Reagents, Specific, Analyte 1 MGB Alert HSV 1&2 Typer Primer Mix ASR - 48 rxn
24 03661540951602 800430 800430 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use a The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-B can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert® Internal Control Set IC2-B, 48 rxn
25 03661540951480 800414 800414 "MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® EBV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from EBV (Epstein-BarrVirus). The mix consists of a total of 3.1 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 61 nucleic acid sequence from thep140 region of the BNRF1 gene of EBV." MVU Reagents, Specific, Analyte 1 MGB Alert® EBV Primer Mix ASR - 48 Reactions
26 03661540951435 800364 800364 The MGB Alert Internal Control Set MS2-M consists of reagents intended for use a The MGB Alert Internal Control Set MS2-M consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set MS2-M can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set MS2-M 48 rxn
27 03661540950360 M800602 M800602 "MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemic "MGB Alert® JC Virus Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the VP2 Tantigen region of JC Virus. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® JCV Probe Mix ASR - 48 Reactions
28 03661540950216 M800582-am M800582-am MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that conta MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect arepeated DNA fragment in Trichomonas vaginalis. The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeledwith 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Trichomonas Vaginalis Probe Mix ASR, 09N42-002
29 03661540950117 800421-am 800421-am MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a che MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert BK Virus Probe Mix ASR, 09N38-002
30 03661540952357 M800727 MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligo MGB Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BKVirus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the majorcapsid protein VP1 gene of the BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV ASR v3.0 Probe Mix
31 03661540951862 800361 800361 The MGB Alert Internal Control Set IC1-C consists of reagents intended for use a The MGB Alert Internal Control Set IC1-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC1-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert®Internal Control 1C Set, 480 rxn
32 03661540951794 M800599-am M800599-am The MGB Alert Platinum Master Mix is intended for use in the development of labo The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data. PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix, 09N41-005
33 03661540951374 800350 800350 "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleoti "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 regionof CMV (Cytomegalovirus). " MVU Reagents, Specific, Analyte 1 MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reaction
34 03661540951664 800497 800497 MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleo MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus.The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all knownAdenovirus types. MVU Reagents, Specific, Analyte 1 MGB Alert® Adenovirus Primer Mix ASR - 48 rxn
35 03661540951510 800418 800418 "MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from VZV (VaricellaZoster Virus). The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the VZV sequence within theORF 38 region." MVU Reagents, Specific, Analyte 1 MGB Alert® VZV Primer Mix ASR - 48 rxn
36 03661540951459 800404 800404 "MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a che "MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from CMV (Cytomegalovirus). The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm andan emission wavelength maxima of 516 nm. " MVU Reagents, Specific, Analyte 1 MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions
37 03661540951329 800337 800337 MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a MGB Alert® Enterovirus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Enterovirus. The mix consists of one probe at 0.14 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert® Enterovirus Probe Mix ASR - 48 Reactions
38 03661540951251 800306 800306 "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides "MGB Alert® hMPV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from hMPV (humanMetapneumovirus). The mix consists of a total of 8.4 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 186 nucleic acidsequence from the Polymerase (L) gene of hMPV." MVU Reagents, Specific, Analyte 1 MGB Alert® hMPV Primer Mix ASR - 48 Reactions
39 03661540950322 M800600 M800600 The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use a The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-8 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-8 48 rxn
40 03661540950193 M800331-am M800331-am The MGB Alert PCR Master Mix package includes ready to use 2x master mix contain The MGB Alert PCR Master Mix package includes ready to use 2x master mix containinga non-Taq thermostable enzyme lacking exonuclease activity and provided in antibodyinactivated form. An initial high-temperature incubation step denatures the antibodies toactivate the enzyme. The master mix also includes Uracil-DNA Glycosylase (UDG) anddUTP to prevent carry-over contamination. MGB Alert PCR Enhancer and MGB Alert 25 mMMgCl2 are provided for additional flexibility in optimizing reaction conditions. PPM General Purpose Reagent 1 MGB Alert PCR Master Mix 09N41-004
41 03661540950179 800498-am 800498-am MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains che MGB Alert® Adenovirus Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to detect nucleicacid sequences within the hexon gene, which is present in all known Adenovirus types. The mix consists of two probes at 1.12 nmol per vial in a 1X TEbuffer solution. The probes are labeled with 6-carboxyfluorescein, which has an excitation wavelength maxima of 492 nm and an emission wavelengthmaxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Adenovirus Probe Mix ASR, 09N40-002
42 03661540950087 M800587-am M800587-am MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucl MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54nucleic acid sequence from the glycoprotein D region of HSV 1 and 2. MVU Reagents, Specific, Analyte 1 MGB Alert HSV-2 Primer Mix ASR 09N45-003
43 03661540950049 M800572 M800572 MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detectnucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probeis labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. MVU Reagents, Specific, Analyte 1 MGB Alert Pneumocystis Probe Mix 48rxn,
44 03661540950001 M800346 MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct dete MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen 2 MRSA/SA ELITe MGB
45 03661540951466 800411 MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleoti MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Primer Mix ASR - 48 Reactions
46 03661540951817 M800693 M800693 The MGB Alert Platinum Master Mix is intended for use in the development of labo The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using real-time PCR. The MGB Alert Platinum Master Mix itself generates no diagnostic information or data. PPM General Purpose Reagent 1 MGB Alert Platinum Master Mix, with water-48rxn
47 03661540951596 800429 800429 The MGB Alert Internal Control Set IC2 consists of reagents intended for use as The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplificationprocess control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemicvariation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is notintended to monitor other real-time PCR processes. OLD Internal Polymerase Chain Reaction Control, Not Assay Specific 1 MGB Alert Internal Control Set IC2-48rxn
48 03661540951572 800426 800426 MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a ch MGB Alert® HSV 1 & 2 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 and 2). The mix consists of one probe at 0.2 nmol per vial in a 1X TE buffer solution. Theprobe dye is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. MVU Reagents, Specific, Analyte 1 MGB Alert HSV 1&2 Typer Probe Mix ASR - 48 rxn
49 03661540951350 800348 800348 MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides d MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV MVU Reagents, Specific, Analyte 1 MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn
50 03661540951282 800333 800333 "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a ch "MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleicacid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm." MVU Reagents, Specific, Analyte 1 MGB Alert® BKV Probe Mix ASR-480rxn
Other products with the same Product Code "OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00840733102370 410500 410500 The revogene Carba assay performed on the revogene instrument is a qualitative i The revogene Carba assay performed on the revogene instrument is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. Revogene Carba C MERIDIAN BIOSCIENCE, INC.
2 00840733102363 410200 410200 The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene GBS LB MERIDIAN BIOSCIENCE, INC.
3 00840733102332 610208 610208 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene instrument and the Revogene assays. The MOCK Pie simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. Revogene Mock Pie MERIDIAN BIOSCIENCE, INC.
4 00840733102325 410400 The revogene Strep A assay, performed on the revogene instrument, is an automate The revogene Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection.The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings. Revogene Strep A MERIDIAN BIOSCIENCE, INC.
5 00840733102318 610210 610210 The system is a clinical multiplex instrument intended to measure and sort multi The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes. Revogene MERIDIAN BIOSCIENCE, INC.
6 00840733102264 480150 480150 The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Aleth The Alethia™ Group A Streptococcus (Group A Strep) assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens. The Alethia™ Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the Alethia™ Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. Alethia™ Group A Streptococcus MERIDIAN BIOSCIENCE, INC.
7 00840733102189 480250 480250 The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary. Alethia™ Mycoplasma Direct MERIDIAN BIOSCIENCE, INC.
8 00840733102127 479910 479910 The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. Alethia™ Group A Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
9 00840733102103 479890 479890 The Alethia Mycoplasma Direct External Control Kit contains Positive Control Rea The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors. Alethia™ Mycoplasma Direct External Control Kit MERIDIAN BIOSCIENCE, INC.
10 00840733101663 610189 610189 Alethia™ is an automated isothermal amplification and detection system for use w Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays. Alethia™ MERIDIAN BIOSCIENCE, INC.
11 00840733101335 280150 280150 The illumigene Group A Streptococcus (Group A Strep) assay, performed on the ill The illumigene Group A Streptococcus (Group A Strep) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens.The illumigene Group A Strep assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome. Results from the illumigene Group A Strep assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. illumigene Group A Streptococcus MERIDIAN BIOSCIENCE, INC.
12 00840733101328 279910 279910 The illumigene Group A Streptococcus (Group A Strep) External Control Kit contai The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Group A Streptococcus External Control Kit MERIDIAN BIOSCIENCE, INC.
13 00840733101281 279890 279890 The illumigene Mycoplasma Direct External Control Kit contains Positive Control The illumigene Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the illumigene Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the illumigene Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Mycoplasma Direct External Control Kit MERIDIAN BIOSCIENCE, INC.
14 00840733101274 280250 280250 The illumigene Mycoplasma Direct DNA amplification assay, performed on the illum The illumigene Mycoplasma Direct DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. illumigene Mycoplasma Direct MERIDIAN BIOSCIENCE, INC.
15 00840733101243 610172 610172 The illumipro-10 is an automated isothermal amplification and detection system f The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc. illumigene Loop-Mediated Amplification products. illumipro-10 MERIDIAN BIOSCIENCE, INC.
16 00840733101175 280550 280550 "The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-1 "The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. illumigene Mycoplasma MERIDIAN BIOSCIENCE, INC.
17 00840733101144 279940 279940 The illumigene Mycoplasma External Control Kit contains Positive and Negative Co The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program. illumigene Mycoplasma External Control Kit MERIDIAN BIOSCIENCE, INC.
18 00840487101537 ARIES M12V1 The ARIES® System is a clinical multiplex test system that automates and integra The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. ARIES® System LUMINEX CORPORATION
19 00840487101490 10-0000-07R 10-0000-07R The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) Verigene® Processor SP (Refurbished) LUMINEX CORPORATION
20 00840487101483 10-0000-07 10-0000-07 The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. Verigene® Processor SP LUMINEX CORPORATION
21 00840487101476 10-0000-02R 10-0000-02R The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) Verigene® Reader (Refurbished) LUMINEX CORPORATION
22 00840487101469 50-10041 The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) ba The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. ARIES® Group A Strep Assay LUMINEX CORPORATION
23 00840487100448 CN-SW47 The SYNCT Software is a desktop application that can be utilized by an end-user The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions. SYNCT™ Software LUMINEX CORPORATION
24 00840487100417 I051C0447 I051C0447 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. NxTAG® Respiratory Pathogen Panel LUMINEX MOLECULAR DIAGNOSTICS, INC
25 00840487100325 10-0000-02 10-0000-02 The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. Verigene® Reader LUMINEX CORPORATION
26 00840487100080 ARIES M6V1 The ARIES® M1 System is a clinical multiplex test system that automates and inte The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. ARIES® M1 System LUMINEX CORPORATION
27 00840487100073 50-10026 The ARIES® Extraction Kit is intended to extract nucleic acid from human biologi The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM). ARIES® Extraction Kit LUMINEX CORPORATION
28 00815381020307 RFIT-ASY-0137 RFIT-ASY-0137 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 plus (RP2plus) BIOFIRE DIAGNOSTICS, LLC
29 00815381020291 RFIT-ASY-0136 RFIT-ASY-0136 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 plus (RP2plus) BIOFIRE DIAGNOSTICS, LLC
30 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC
31 00815381020093 RFIT-ASY-0127 RFIT-ASY-0127 IVD reagent kit containing 6 tests. FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC
32 00815381020086 RFIT-ASY-0126 RFIT-ASY-0126 IVD reagent kit containing 30 tests. FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC
33 00628055344179 410400 410400 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automa The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. Revogene® Strep A MERIDIAN BIOSCIENCE CANADA INC
34 00628055344162 410500 410500 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. Revogene® Carba C MERIDIAN BIOSCIENCE CANADA INC
35 00628055344131 610208 610208 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. MOCK PIE MERIDIAN BIOSCIENCE CANADA INC
36 00628055344117 410200 410200 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
37 00628055344100 610210 610210 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in perfor The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR. Revogene® MERIDIAN BIOSCIENCE CANADA INC
38 00628055344087 133674 133674 The GenePOC Strep A assay, performed on the revogene instrument, is an automated The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. GenePOC™ Strep A GENEPOC INC
39 00628055344070 133499 133499 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. GenePOC™ Carba GENEPOC INC
40 00628055344032 132331 132331 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run. MOCK PIE GENEPOC INC
41 00628055344001 130840 130840 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in perfor The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. revogene™ GENEPOC INC
42 00382904439859 443985 443985 BD MAX™ Enteric Viral Panel BD MAX™ Enteric Viral Panel BECTON, DICKINSON AND COMPANY
43 00382904437121 443712 443712 BD MAX™ Vaginal Panel BD MAX™ Vaginal Panel BECTON, DICKINSON AND COMPANY
44 00382904434618 443461 443461 Kit BD Max MRSA XT BD MAX™ MRSA XT BECTON, DICKINSON AND COMPANY
45 00382904434199 443419 443419 Kit BD MAX StaphSR BD MAX™ StaphSR BECTON, DICKINSON AND COMPANY
46 00382904433802 443380 443380 BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction T BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer BD MAX™ Enteric Parasite Panel (US/CAN) GENEOHM SCIENCES CANADA INC
47 00382904433789 443378 443378 Kit BD Max Enteric Bacterial Panel USA BD MAX™ Enteric Bacterial Panel (US/CAN) GENEOHM SCIENCES CANADA INC
48 00382904429638 442963 442963 Kit BD MAX Enteric Bacterial Panel BD MAX™ Enteric Bacterial Panel BECTON, DICKINSON AND COMPANY
49 00382904429607 442960 442960 BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x BD MAX™Enteric Parasite Panel Contains: 24 Master Mix, 24 Extraction Tubes, 24 x 1.5mL Sample Buffer Tubes, 25 x Septum, 24 x Strips BD MAX™ Enteric Parasite Panel BECTON, DICKINSON AND COMPANY
50 00382904429584 442958 442958 BD Viper™ LT System SDA Accessory Kit BD Viper™ LT System SDA Accessory Kit BECTON, DICKINSON AND COMPANY